Pain Management Groups in Occupational Health Settings
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pain management group
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain focused on measuring Pain Management, Chronic Pain, Health Services, Occupational Health
Eligibility Criteria
Inclusion Criteria:
- chronic pain + increased risk of work disability (based on a screening survey)
Exclusion Criteria:
- a malignant disease such as cancer, or severe mental illness such as depression causing significant functional disability.
- participating in another pain group elsewhere.
- in the middle of a major life crises such as divorce.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pain management group
Treatment as usual
Arm Description
6 + 1 meetings 2 hours each
Waiting list - will receive treatment as usual
Outcomes
Primary Outcome Measures
Pain intensity
self-reported questionnaire, 1-item question, scale 0-10, n=60
Pain self-efficacy
self-reported questionnaire, set of 10 questions, item response scale 0 - 6, n=60
Chronic pain acceptance
self-reported questionnaire, set of 8 questions, item response scale 0 - 6, n=60
Fear-avoidance beliefs
self-reported questionnaire, set of 3 questions, item response scale 0 - 6, n=18
Depressive symptoms
self-reported questionnaire, 1-item question, response scale 0-10, n=60
Sleep problems
self-reported questionnaire, 1-item question, response scale 0-10, n=60
Work ability
self-reported questionnaire, 1-item question, response scale 0-10, n=60
Secondary Outcome Measures
sickness absence
register based, number of sick leave days
health care contacts
register based, number of contacts to OHS
Full Information
NCT ID
NCT02967705
First Posted
October 20, 2016
Last Updated
November 25, 2019
Sponsor
Finnish Institute of Occupational Health
Collaborators
Finnish Work Environment Fund, Työterveys Helsinki (Helsinki city occupational health service)
1. Study Identification
Unique Protocol Identification Number
NCT02967705
Brief Title
Pain Management Groups in Occupational Health Settings
Official Title
Study on Pain Management Groups in Occupational Health Settings
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Finnish Institute of Occupational Health
Collaborators
Finnish Work Environment Fund, Työterveys Helsinki (Helsinki city occupational health service)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This cluster randomized waiting-list controlled study will evaluate the effectiveness of pain management group activity organized by the OH on pain intensity and associated disability, and co-occurrence of mental or sleep problem in patients with chronic pain.
Detailed Description
Pain is very prevalent among the working population causing a considerable amount of work disability days. Pain management group therapy has shown to have a significant effect on chronic pain. However, little is known of the effect of such therapy on work disability. There are especially very few studies prescribing the effectiveness of pain management groups provided by the occupational health service.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Pain Management, Chronic Pain, Health Services, Occupational Health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pain management group
Arm Type
Experimental
Arm Description
6 + 1 meetings 2 hours each
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Waiting list - will receive treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Pain management group
Intervention Description
Chronic pain patients participate in a peer group. They are provided information about chronic pain self-management based on biopsychosocial framework.
Primary Outcome Measure Information:
Title
Pain intensity
Description
self-reported questionnaire, 1-item question, scale 0-10, n=60
Time Frame
Change in pain intensity from before intervention to immediately after intervention and at 6 months
Title
Pain self-efficacy
Description
self-reported questionnaire, set of 10 questions, item response scale 0 - 6, n=60
Time Frame
Change in pain self-efficacy from before intervention to immediately after intervention and at 6 months
Title
Chronic pain acceptance
Description
self-reported questionnaire, set of 8 questions, item response scale 0 - 6, n=60
Time Frame
Change in chronic pain acceptance from before intervention to immediately after intervention and at 6 months
Title
Fear-avoidance beliefs
Description
self-reported questionnaire, set of 3 questions, item response scale 0 - 6, n=18
Time Frame
Change in fear-avoidance beliefs from before intervention to immediately after intervention and at 6 months
Title
Depressive symptoms
Description
self-reported questionnaire, 1-item question, response scale 0-10, n=60
Time Frame
Change in depressive symptoms from before intervention to immediately after intervention and at 6 months
Title
Sleep problems
Description
self-reported questionnaire, 1-item question, response scale 0-10, n=60
Time Frame
Change in sleep problems from before intervention to immediately after intervention and at 6 months
Title
Work ability
Description
self-reported questionnaire, 1-item question, response scale 0-10, n=60
Time Frame
Change in work ability from before intervention to immediately after intervention and at 6 months
Secondary Outcome Measure Information:
Title
sickness absence
Description
register based, number of sick leave days
Time Frame
6 months before and 6 months after intervention
Title
health care contacts
Description
register based, number of contacts to OHS
Time Frame
6 months before and 6 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- chronic pain + increased risk of work disability (based on a screening survey)
Exclusion Criteria:
a malignant disease such as cancer, or severe mental illness such as depression causing significant functional disability.
participating in another pain group elsewhere.
in the middle of a major life crises such as divorce.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena Miranda, Dr.Med.Sc.
Organizational Affiliation
Helsinki City OHS
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Pain Management Groups in Occupational Health Settings
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